Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey G. Jarvik, MD, MPH, University of Washington
ClinicalTrials.gov Identifier:
NCT00032227
First received: March 12, 2002
Last updated: May 4, 2013
Last verified: May 2013
  Purpose

The Carpal Tunnel Syndrome Diagnosis and Treatment Trial is project #1 of the Multidisciplinary Clinical Research Center focused on upper extremity pain. It is a randomized trial comparing surgical and nonsurgical treatments for patients with early, mild to moderate carpal tunnel syndrome. In addition the study will evaluate the ability of a new magnetic resonance (MR) technique at predicting who will likely benefit from carpal tunnel syndrome (CTS) surgery.


Condition Intervention
Carpal Tunnel Syndrome
Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS
Other: MR Nerve Imaging for CTS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Carpal Tunnel Syndrome Assessment Questionnaire- function scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CTSAQ symptom scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • CTSAQ-function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • CTSAQ-symptom [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • SF36 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: August 2002
Study Completion Date: April 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Surgical release of CTS
Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS
Either open or endoscopic surgery
Other: MR Nerve Imaging for CTS
New diagnostic test for CTS to directly image the median nerve
Active Comparator: 2
Non-surgical treatment for CTS (splint, physical therapy, ultrasound)
Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS
Either open or endoscopic surgery
Other: MR Nerve Imaging for CTS
New diagnostic test for CTS to directly image the median nerve

Detailed Description:

While there is good evidence that patients with severe CTS benefit from surgery, there is less evidence of a benefit for patients with mild to moderate disease. However, mild to moderate disease still accounts for important disability. Electrodiagnostic studies (EDS) have not been shown to accurately predict outcomes for patients with CTS. Recent advances in MR permit high-resolution neurographic imaging of the median nerve, and pilot data suggest that wrist MRI might be a better predictor of outcome than EDS. Thus, wrist MRI has the potential for playing a major role in the treatment of patients with CTS. We will test two main hypotheses: 1) that select patients with early, mild or moderate CTS benefit more from early surgery than with conservative therapy; and, 2) that wrist MRI accurately identifies those patients more likely to benefit from surgery. We will perform a randomized, controlled treatment trial nested within a prospective cohort as our study design.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Paresthesias involving 2 digits on hand diagram
  • Willingness and ability to complete interviews

Exclusion Criteria:

  • Evidence of denervation on EDS
  • Abnormal 2-pt discrimination or thenar atrophy
  • Prior wrist surgery or acute external trauma
  • MRI contraindications
  • Metallic hardware in wrists
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032227

Locations
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Jeffrey G. Jarvik, MD, MPH University of Washington
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey G. Jarvik, MD, MPH, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00032227     History of Changes
Other Study ID Numbers: P60 AR48093, P60AR048093, NIAMS-075
Study First Received: March 12, 2002
Last Updated: May 4, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Carpal Tunnel Release
MR Nerve Imaging
Wrist MRI

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014